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FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE

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FDA Registration Number Search & Verification

This article explains how to verify FDA registration numbers for facilities and products in the following industries.

  • Food Facility Registrations FFR
  • Cosmetic Facility Registrations &  Product Listings
  • Medical Device  Registrations & Device Listings
  • Drug Establishment Registrations & NDC Directory
  • FDA Establishment Identifier FEI

 

FDA registration numbers are essential for marketing products in the U.S. The FDA assigns a unique registration number to each registered facility to facilitate the import of goods into the US, assist in facility inspections, and track facility activities.

FDA-registered companies often check the FDA website to confirm their registration numbers. However, due to confidentiality, not all the FDA registration information is publicly accessible.

1) FDA Food Facility Registrations (FFR)

There is no FDA public database from which you can search and verify a food facility’s registration (FFR) information, regardless of whether you are the registered food facility’s owner or trade partner. You can get help for verification by contacting FDA Food Facility Registration Support Services at +1 240-247-8804 or [email protected].

If your FFR registration is valid and needs renewal, we can help you renew your current registration by acting as your new FDA agent if you provide us with your FDA registration number & PIN code. The FDA number is 11 digits, and the PIN code is a combination of upper- and lower-case letters and numbers that can be obtained from the last agent in charge of registration. If you cannot access your PIN, you may get it from the FDA by submitting a request on your official company letterhead to [email protected]. Upon renewal, you will receive an FDA registration certificate that can be used as proof. Our renewal service includes playing the role of U.S. agent for foreign facilities.

Note: If you have not renewed your food facility registration at the end of even-numbered years (2022 or 2024, and so on), the FDA will automatically invalidate and remove your FFR registration. If your FDA number is expired, we can help you re-register your food facility and provide your new FFR number and a registration certificate. You may email or call us for assistance.

FDA FSMA & Import alert Data Search: US food importers must assess relevant FDA regulations and the food supplier’s compliance history, including any FDA warning letters, import alerts, or other compliance actions, and document their findings. Such history is accessible on the FDA firm and supplier and Import Alert databases below.

 

Firm/Supplier Evaluation Resources Database

FDA Import Alert Database (Real Time)

2) FDA Cosmetic Facility Registrations & Cosmetic Product Listings (MoCRA)

The FDA does not offer a public database for cosmetic facility registration and product listings, regardless of whether you are the owner, operator, or agent-in-charge. For general questions and verifications of cosmetic facilities and cosmetic product listings, you can contact the FDA directly at [email protected]. For information about how to renew cosmetic facility registration or product listing, please refer to How to Renew FDA Registration. If you need help with cosmetic facility registration and product listing, you may email or call us for assistance.

3) FDA Medical Device Establishment Registrations & Device Listing

The FDA provides a public database for registered medical device establishments. Upon registration, each establishment receives an owner/operator number that could be accepted as an FDA registration number for shipment clearance purposes. However, the FDA can take 90 days to assign an official FDA number (FEI) to a device establishment. 

Remember that some information on medical device establishment registration, known as the device listing number, will not become publicly accessible. Medical devices must be cleared to enter the US market with a valid device listing number. The FDA wants to honor medical device establishments’ sovereignty and exclusivity rights over the import and marketing of their products.

FDA-approved medical devices, primarily devices class II,  can access the records through a process known as 510k. Also, the FDA Global Unique Device Identification Database (GUDID) contains essential device identification information submitted to the FDA about medical devices that have submitted Unique Device Identifiers (UDI). Companies at the earliest stage of device registration may need to classify their medical devices for proper medical device class identification and listing. The Device Classification database contains device names and their associated product codes that identify the generic category of a device for the FDA.

For information about renewing medical device registration and listing, please refer to How to Renew FDA Registration. You may email or call us for help with medical device registration and listing.

4) Drug Establishment Registrations & NDC Directory

The FDA offers a public database for registered drug establishments. Whether they are manufacturers, packers, or labelers of OTC or prescription drugs, their registration records will be published in the following database. The FDA National Drug Code NDC directory contains a complete record of finished, API, and compounded human drug products currently listed by the FDA as valid and live. Drug products not re-certified in time will automatically be removed from the NDC directory. The drug information could be accessed via the drug’s proprietary name, 10 or 11-digit NDC code, or labeler data. 

Due to confidentiality matters, certain drug records created under a brand owner entity labeler code will not be published in the NDC directory: such records could be verified by contacting the FDA Electronic Drug Registration and Listing System (eDRLS) at [email protected].

The FDA additionally offers access to the list of facilities registered as human drug compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.  The FDA also provides the list of Drug Master Files (DMFs) it has received containing the DMF activity status (A=active; I=inactive), DMF type, holder name, and subject.

Please refer to How to Renew FDA Registration for information about renewing drug establishment registration or listingYou may email or call us for help with drug establishment registration and listing.

5) FDA Establishment Identifier FEI

An FDA Establishment Identifier or Firm Establishment Identifier (FEI) is an FDA system-generated number used to identify a firm. The FDA’s FEI Portal allows users to look up an FDA Establishment Identifier (FEI) based on a firm’s name and address or validate an FEI’s address. To access the FEI search portal, the users must first create an account and log in. If you can’t find an FEI using the FEI Portal for your firm or the firm you represent, see “How can I request an FEI?” in the FEI Portal Frequently Asked Questions (FAQ).

Service Details & Fees

Food Facility Registration

U.S. Agent Representation

Time to Completion

Food Facility Renewal

Certificate of FDA Registration

Registration Verifications

395 USD

295 USD

1 Day

_______ Related Services _______

Service Details & Fees

Food Facility Registration

395 USD

U.S. Agent Representation

295 USD

Time to Completion

1 Day

Food Facility Renewal

Certificate of FDA Registration

Registration Verifications

_______ Related Services _______

FDA Service Assistance Request Form*

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